Men hoping to avoid some of the dreaded side effects of prostate cancer treatment are shelling out tens of thousands of dollars for a new procedure whose long-term effects are unknown, even though insurers, including Medicare, generally won’t pay for it.

Proponents say high-intensity focused ultrasound (HIFU) has comparable short-term results and may have fewer side effects than surgery or radiation, while giving some patients another option between actively monitoring their cancer for signs of spread and those more aggressive steps. Critics, however, say the procedure is being oversold, leading some patients to get a treatment they don’t need.

Device makers are busy selling the $500,000-and-up machines to doctors around the country and offering training courses. Billboards advertising this “new noninvasive treatment for prostate cancer” are springing up, while treatment center websites promise “a safer method” with benefits such as “no erectile dysfunction and no incontinence.”

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But studies show that for patients undergoing treatment of the whole prostate, rates of erectile dysfunction are similar to those for more aggressive treatments, although incontinence rates are lower. When only part of the gland is treated, which proponents liken to a lumpectomy for women with breast cancer, side effects are reduced, but not eliminated, according to some studies.

HIFU is the latest treatment to prompt concerns over whether there should be limits — such as requiring tracking of results — placed on expensive new technology while additional data is gathered.

“This is going to join the group of uncertain-yet-available therapies that physicians can use, yet we have no clear understanding of who will benefit in a real world population,” said Art Sedrakyan, a professor of health care policy and research at Weill Cornell Medicine in New York. The treatment of prostate cancer has been a particularly controversial — and lucrative – niche, because the disease for some men can be slow-growing.

A host of new “nonsurgical’ treatments are now also available using sophisticated machines to destroy cancer cells with proton beams or other types of high-dose radiation.

Using HIFU, a device directs ultrasound waves to heat prostate tissue to about 195 degrees, destroying all or portions of the gland. Focusing on what is considered the main tumor and only removing that is a newer trend in prostate cancer treatment. Anesthesia is used.

HIFU machines have been used in Europe longer than in the United States, although national health programs in the United Kingdom and elsewhere limit coverage to patients enrolled in clinical trials or other research programs. While the devices are approved in Canada, the national health program does not pay for it. Until recently, some men in this country traveled to have the procedure done by US doctors who set up shop in Mexico, the Bahamas, or Bermuda.

In the United States, advisory committees to the Food and Drug Administration twice recommended against applications from manufacturers to market HIFU devices as a treatment for prostate cancer, citing an insufficient amount of long-term evidence.

But in October 2015, the FDA approved Charlotte, N.C.-based SonaCare Medical’s device — not for the treatment of prostate cancer per se, but for the ablation of prostate tissue. Data submitted by the company included an analysis of 116 men who had their entire prostate treated and were followed for 12 months. “While the oncological outcomes from this study are inconclusive, the results provide reasonable assurance of safety and effectiveness of the device in the context of prostate tissue ablation,” the FDA said in its review.

A device by Lyon, France-based EDAP gained a similar approval shortly thereafter.

SonaCare said it has sold more than 30 of the machines in the United States, with medical centers in California, Florida, New York, North Carolina, and Texas already using them. EDAP reported in late August that earnings from its HIFU division rose 68 percent in the first six months of 2016.

Researchers say it’s too soon to state conclusively that partially ablating the gland works as well as totally removing it. There is also debate over the type of patients best suited for the treatment: low risk, intermediate risk, or those who have failed other types of prostate cancer treatment.

Ongoing and previous studies from abroad are available, but have limitations, including fairly short follow-up periods.

“The biggest studies in the world are only four or five years into it,” said Michael Koch, chairman of the urology department at Indiana University School of Medicine, a proponent of HIFU for some patients. “We don’t have survival data to see if [it] does better than surgery or radiation.”

To get more complete answers, some physicians say it’s critical to track outcomes with de-identified patient information in a nationwide registry.

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It’s not a new idea. Indeed, some technologies have been granted approval by the FDA or coverage by Medicare with a condition that patients must be enrolled in clinical trials or registries.

“Short of the FDA saying to device makers, ‘You need to do this’,” establishing a comprehensive tracking method is challenging, said Jim Hu, a urologist and a robotic surgery specialist at Weill Cornell.

Hu coauthored a paper in the Journal of the American Medical Association in July with Sedrakyan and UCLA urology resident Aaron Laviana, calling for a registry. Meetings between registry proponents, the FDA, and the device makers are ongoing, but challenges remain, Hu said, particularly around who would pay for such a registry.

“The financial piece of this is somewhat perverse,” he said. “Men are being charged $25,000 for this, yet no one feels pressure to demonstrate the efficacy of the treatment.”

A registry is currently operating in England that will soon open to US users of SonaCare Medical’s HIFU devices. While SonaCare funds the registry, which contains data only on its devices, the firm does not have control of the data, said SonaCare CEO Mark Carol. His firm will also contribute some funding to a broader US registry that Hu and his coauthors support, which would incorporate results from other HIFU devices, as well.

The evidence gathered could convince Medicare and other insurers that a treatment is valuable — and worth covering. But some practitioners may not want insurers to cover the treatment because when a treatment isn’t covered, cash payments by patients can often exceed what physicians would be paid by insurers. Currently, men usually pay for it themselves, with some successfully appealing to their insurers to cover part of the cost, said Carol.

Ultimately, insurance coverage will be needed for HIFU “to have as large a reach as possible,” said Carol. But in the meantime, surgeons using the device with cash-paying patients may not be in a rush for that to change.

“From an economic point of view, [insurance coverage] is a mixed bag” he said, because coverage usually means lower payments and surgeons would “have to treat three or four times as many patients to cover the cost of the technology.”

While registries are useful they also have limitations.

For one thing, because they are not randomly controlled trials, registries aren’t the best way to compare treatment A to treatment B, said Fred Masoudi, a professor at the University of Colorado’s medical school. But they can show how treatments, drugs, or devices perform in common use.

“It’s not a foregone conclusion that results will be the same [as in clinical trials], which is why registry programs are so important,” said Masoudi, who has been involved with other such registries.

Adding a new treatment alternative

Meanwhile, uncertainty regarding patients’ best treatment options has created an opportunity for HIFU.

Surgery and radiation can pose problems such as incontinence or impotence; while hormonal treatments also cause impotence and can also result in hot flashes, muscle weakness, and other problems.

When the cancer is aggressive, the benefit of these approaches outweigh such side effects. But for men with lower-risk profiles, based on factors such as age, and results of tests and biopsies, the choice is more difficult. Their tumors may grow so slowly that the cancer wouldn’t be fatal for many of these men. Some health care experts encourage these patients to opt for “active surveillance,” which means keeping an eye on the cancer through regular testing. A study published last month showed that men with early prostate cancer who chose active monitoring had the same small risk of dying of their cancer over the next 10 years as men who underwent surgery or radiation.

But some men are uncomfortable just watching — and that’s where HIFU could play a role.

Patients who have an area in the prostate with a higher-grade tumor could choose to treat just that portion with HIFU, said Indiana University’s Koch, who was part of the clinical trials of SonaCare’s device and has accepted funding from the company.

“If we can treat [that area] with therapy, we can get them back on active surveillance,” said Koch.

Others say more study is needed.

With prostate cancer, there may be a dominant tumor but small cancer cells elsewhere in the gland, said Justin Beckelman, associate professor of radiation oncology at the University of Pennsylvania.

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Still others note that patients who choose HIFU need to select physicians with lots of experience and training because the procedure is complex.

“HIFU is a steep learning curve. Some of the doctors buying these machines are not ready for it,” said Jim Wickstrom, who had the procedure four years ago in Bermuda and is a big proponent. He said patients should do their research and choose only very experienced physicians who are willing to show their outcome data.

Wickstrom chose HIFU after studying his options and looking at data from Europe and Japan. “There’s a lot of controversy about no data, but HIFU has been done in other countries for a long time,” said Wickstrom, who had his whole gland ablated.

So far, he’s been pleased: “Everything could not have gone better. I came out of HIFU with no pain or incontinence or impotence.”

Kaiser Health News is a national health policy news service that is part of the nonpartisan Henry J. Kaiser Family Foundation.

My husband, age 65, just had HIFU 9 days ago to ablate his whole prostate. So far, the only discomfort has been from the catheter and from irritated hemorrhoids which were disturbed by the HIFU probe. In retrospect, he would have had the hemorrhoids taken care of before the HIFU. As for the HIFU itself, he has had no pain or discomfort. Only time will tell about any long term affects, but our son, a PA at a men’s clinic, highly recommended HIFU.

HIFU has been proven safe and effective with over a decade of data from European and Asian studies. It’s proven as effective as radical therapies (the article that this article refers to for “whole gland treatment” states that) and the side effects of incontinence and erectile dysfunction are much lower than those other options. This article is a hatchet job, you state whole gland treatments with HIFU result in similar rates of erectile dysfunction but lower incontinence; ok, but you’re missing the point. HIFU can target just the tumor and leave the rest of the gland alone. If it’s a single tumor then it can ablate just that tissue. If it’s multiple tumors then 80% of the time the largest one has the highest chance at metastasis and you only need to treat that tumor. Leaving as much of the gland untouched as possible greatly reduces incontinence and greatly improves erectile function rates over other more radical therapies. If the Dr uses an EDAP HIFU robotic device the numbers are even better according to some of the material I’ve seen; admittedly this could just be marketing. Either way, if given the chance between this and a “wait and see approach” a man would have to be a fool to not want this. What’s happening here is another great example of those with “money to lose” in old therapies trying to stop progress from occurring. As far as the what Magnus said below; in this case the FDA is\was trying to stop this tech from being approved but the evidence is just too much to stop this technology. The article rails against Dr’s who take the chance and are trying to provide a safer solution to Prostate cancer treatment and instead of asking why insurance companies won’t cover the procedure thus setting payment rates and reducing costs, it paints the Dr’s as greedy. Again this whole article and the source Kaiser article are hatchet jobs paid for by those organizations that are providing the radical therapies, that may help, but also lower the patient’s qualify of life with incontinence and sexual dysfunction. The FDA needs to approve this for it’s full function and insurance companies need to start coverage NOW.

To the author-
Here are a few easy reads for you:
1. Uchida, Toyoaki et al. “Improved Outcomes with Advancements in High Intensity Focused Ultrasound Devices for the Treatment of Localized Prostate Cancer.” The Journal of Urology 193.1 (2015): 103–110.

Our FDA is aligned more with industry companies interests than with the public and patients harmed. That is an unacceptable violation of their mission as a federal public health agency!
The entire culture at the FDA needs to change. The days of letting the FDA treating industry as a client rather than a regulated entity must come to an end.
Dr. Shuren (CDRH director), focus’s far more on industry’s needs to get “innovative and life-saving devices” on the market efficiently rather than patient safety. He is married, by the way, to a prominent lawyer whose clients include “pharmaceutical, medical device, and biotechnology companies,’’ as her biography indicates.
Most American’s have been conditioned to trust “FDA approval.” Whether it’s an antidepressant, cholesterol-lowering drug or blood pressure med, medical devise, etc. FDA approval is thought to represent a full endorsement for safety and efficacy. I’ve watched FDA standards erode to the point that makes “FDA Approval” the first sign of DANGER!
In 2004, former head of the FDA – Lester M. Crawford – pleaded guilty to lying and conflict-of-interest charges in connection with stock he and his wife owned in companies he regulated as chief of the FDA!
The scandal has been going on for decades. Back in 1994, a Vermont Congressman asserted that the FDA collaborated with the manufacturer of a genetically engineered dairy hormone in clearing the new drug for approval and sale!
This is business as usual for Big Industry and the FDA. Yet, the masses keep swallowing the hype! Sadly, the outcome of weak FDA standards has become all too clear.
Relaxed FDA standards stem from conflicts of interest among the FDA. According to USA Today, more than half of the experts hired by the FDA to advise the government on the safety and effectiveness of medicines have direct financial relationships with the Industry Companies who will either be helped or hurt by the decision of FDA approval. These conflicts include helping a pharmaceutical company invent a medicine, then serving on the FDA advisory committee which then decides whether the drug will be approved for human consumption. Most conflicts are in the form of stock ownership and obtaining consulting fees or research grants from the drug industry.
A USA Today analysis of financial conflicts of interest shows the following, based on 159 FDA advisory committee meetings:
– 92% of the meetings had at least one member who had a financial conflict of interest.
– At 55% of advisory meetings, at least half, sometimes more among the FDA advisers, had conflicts of interest
– Financial conflicts of interest were most frequent at the 57 meetings when broader issues were discussed: 92% of members had conflicts
– At 102 meetings dealing with the fate of a given drug, 33% of the experts in attendance had a financial conflict

Historically the FDA revealed when these financial conflicts were present, but these conflicts have been kept secret lately. None since then? Really?

In addition to lowering approval standards, “Industry Companies” have ensured that the FDA is well compensated for their efforts.

Pharmaceutical campaigning also led to the Prescription Drug User Fee Act (PDUFA) of 1992 and its reauthorization in 1997. The PDUFA allows the FDA to collect fees from pharmaceutical companies to review new drug applications. This sets a new precedent in drug approval. Previously, the United States treasury funded the FDA. However, with the PDUFA, they now receive their paychecks directly from the pharmaceutical industry. This ensures that the FDA remains a lap dog to the pharmaceutical industry does it not?

It appears that there is an ‘old boys’ network” of Industry advisors that rotate between the Industry and FDA ─ at times serving both simultaneously… The Department of Health and Human Services has become complacent in its implementation of the legal requirements on conflicts of interest and committee management. If the law is too loose, we need to change it. If the agencies aren’t doing their job, they need to be held accountable.
What is at issue is not whether researchers can be bought in the sense of a quid pro quo; at issue is that close and financially rewarding collaboration with a company naturally creates goodwill on the part of researchers and the hope that the “gravy train” will continue. Can the FDA really believe that scientists and doctors are more immune to self-interest than other people?

The people in charge (FDA officials) don’t say ‘Should we approve this devise?’ They say ‘Hey, how can we get this devise approved’. The people who approve a devise when they see that there is a safety problem with it are very reluctant to do anything about it because it will reflect badly on them. They continue to let the damage occur!

The conflict of interest amongst the FDA has become so apparent that it has caught the attention of major university researchers. A team of Harvard University professors has publicly advised physicians NOT to prescribe new drugs to their patients because their safety has not been established, despite FDA approval.

Call it human nature, greed, or just plain old corruption; the protective mechanism that was once the driving force of the FDA is gone. The FDA has a bunch of “skeletons in the closet” and has repeatedly shown blatant disregard for the public’s health while enriching its Industry partners.

As the Industry business has grown, the FDA has changed from an institution that was trying to protect public health from bad food to a rubber stamp government organization that only takes public health into account when it is forced to by some form of gross publicly made error. As currently configured the FDA is not able to adequately protect the American people.

Go there for the truth on the 2 million dollar robots that also falsely advertise on billboards etc… THAT’S THE SNAKE OIL 2.0 SCAM OF THE CENTURY! NO PROVEN BENEFITS OVER TRADITIONAL LAP. SURGERY! THEY SETTLE CIVIL CASES (paid 200 million so far) not one single jury verdict…yet. The next trial is scheduled for October 31, 2016. (THEY WILL SETTLE- guaranteed!)
IF the public knew… The companies only product might be pulled (If the FDA wasn’t corrupt). THAT WOULD BE “NEWS”!